Surgical attachment device

ABSTRACT

A hybrid medical device that can aid in reconstructive or augmentative surgery of the breast is disclosed. The device can utilize a suitable biological collagen tissue matrix combined with a synthetic material, for example, that can impart a high initial strength to the repair site while permitting proper healing and revitalization of the implanted device.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a divisional application of U.S. patentapplication Ser. No. 14/640,014, filed Mar. 5, 2015, which claims thebenefit of U.S. Provisional Application No. 61/948,518, filed Mar. 5,2014, both of which are incorporated by reference herein in theirentireties.

BACKGROUND

1. Technical Field

The present disclosure relates to implantable repair matrices and moreparticularly to combination matrices wherein the implantable materialcan have a biologic matrix and an integrated supporting syntheticmatrix.

2. Description of the Related Art

Breast reconstruction surgery (BRS) encompasses several techniques forreproducing the shape and size of a breast that has been lost because ofa mastectomy. Often these end-points are unpredictable, as a surgeoncannot predict with 100% confidence how a reconstructed breast willheal.

Generally, while BRS may be performed at the same time as themastectomy, or delayed for sometime after the initial removal surgery,pockets are formed under the pectoralis muscles in preparation forimplant placement. When the pockets are formed for the implants, apatient's tissue typically requires expansion or stretching.

Certain complications may present during healing of a reconstructedbreast. Among these are infection, pain, contraction and/or implantmigration. It has been shown that placement of a biologic support inconjunction with a separate implant may help alleviate many or all ofthese complications. However, these biologic supports are limited intheir ability to control and shape physical properties of the implant.

There is a need for devices which support natural breast tissue orimplant devices and which allow greater control of surgical positioningof implants, post-operative healing of the reconstruction site as wellas long term health and appearance of the reconstructed breast.

SUMMARY OF THE INVENTION

A surgical attachment device, such as a hybrid implantable breastreconstruction/augmentation device for maximal control and support of anassociated breast implant while minimizing healing time andpost-operative complications, is disclosed. The hybrid device can have aprocessed biologic sheet or scaffold that can have a synthetic material.The synthetic material can be in the form of threads, webs, sheets orcombinations thereof. The device may have single or multiple layers ofscaffold. The device may contain integrated synthetic biodegradable ornonbiodegradable polymer material for the reconstructive procedure.

The biologic component may have one or more layers of a biologicmaterial that are capable of remodeling and/or revitalizing so as tointegrate with the host. For example, allogeneic or xenogeneic materialssuch as collagen sheets, dermal matrices, organ matrices, epithelialsubstrata matrices such as bladder; pericardium; intestinal submucosallayers; stomach; forestomach or other digestive tract submucosa;stomach; forestomach sub-epithelial collagenous layers or otherepithelial or endothelial sub-strata layers.

The device may have combinations of biological scaffold layersintermingled with layers of synthetic material. Such synthetic materiallayers may be comprised of non-degrading biomaterials such as PET,Polypropylene, PTFE ePTFE; or biodregrading materials such as PGA; PLA;PLLA; peL; nylon, silk or collagen based materials.

The layers may have been bonded at certain areas by tissue welds,biological or surgical adhesives or suture type materials in order tofacilitate the optimal surgical placement and integration of the device.

The device may have a polymer or bonding reinforcement of tissue ortissue/synthetic polymer combination in a highly controlled manner. Forexample, bonding or suture patterns may create an anisotropic membrane;polymer or bonding rich sites to create seams for complexthree-dimensional shaping (for example cupping, tabs, pockets, curves);engineering the polymer or bonding sites to provide localized suturereinforced zones as in tissue-to-muscle-wall attachment; using theproperties of polymer or bonding sites to change the tissue's ability toheal or scar as in, for example, anchoring implants and device in placeto prevent or minimize migration of the implant; the use of integratedtethers to aid in placement as in minimally invasive implantationtechniques.

The suture or thread material can have a variable diameter, materialtype, monofilament or braided multi-filament and/or resorbable vs.non-resorbable. The device can have focal areas of increased suturedensity; increased number of tissue layers or multi-layer bonds mayprovide attachment points suitable for external suture application,modulate healing response, encourage endogenous tissue formation,promote or modulate adhesions or other mechanisms which are designed tosecure the matrix to the implant site or control the healing response.

Individual layers of a multi-layer device may be constructed so that thedensest suture patterns are confined to the inner layer or layers withthe outer layers minimally sutured or otherwise anchored in place. Uponimplantation, the minimally attached, penetrated or otherwisecompromised outer layers of the device serve to minimize the potentialfor abrasion, inflammation and/or adhesion formation when in contactwith surrounding tissue. Layers of synthetic biodegradable ornon-biodegradable material may be interleaved with layers of biologicalmaterial to provide, for example, maintenance of shape, increasedstrength, release of bioactive compounds, maintenance of shape duringremodeling or to provide reservoirs for cells or bioactive products.

The device can have structured gradients in material properties of thedevice. For example, gradients in strength, elongation or thickness, forexample, by variations in density of suture or thread penetrations; theintegration of suture or thread patterns or designs into the device orthe inclusion of varied numbers of layers of biologic or syntheticmaterial within a hybrid construct so as to provide localized areas ofincreased or decreased layer number.

The multiple layers of biologic material or defined areas of thebiologic layer material may be held in approximation to other layers viamechanisms such as, glues or adhesives, tissue welding, or combinationsthereof.

The glues or adhesives can be organic, natural or synthetic. Theadhesives may comprise bio-compatible “super glue” type cyanoacrylate ormethacrylates, bio-type glues such as fibrin/thrombin, light-activatedadhesive materials, or combinations thereof.

The tissue welding techniques can be thermal, ultrasound, RF or IRenergy patterns, the use of other wavelengths of electromagnetic energysuch as laser type concentrated energy sources, or combinations thereof.

The device can have various holes, apertures, slits, pores or otherfluid transport and/or control features, or combinations thereof. A slitcan be a cut without material removal into a single or multiple layersof the device. The slits may be uni-directional (i.e existing along oneaxis of the device) or multi-directional. The fluid transport and/orcontrol features can manage fluid transport within or through theimplanted matrix construct as in, for example prevention ofpostoperative seroma formation. These transport or control features maybe aligned or offset through adjacent layers of a multi-layer constructdevice and could, for example, be produced via die cutting, water jet,laser or combinations thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 through 11 illustrate variations of the device.

FIGS. 12a through 12c illustrate a variation of the device and a methodfor using the same.

FIG. 13 illustrates a variation of the device.

FIGS. 14a through 14c are perspective, bottom, and side views,respectively, of a variation of the device.

FIGS. 15 and 16 illustrate variations of the device duringmanufacturing.

FIGS. 17a through 17c are variations of perspective, front, and sideviews of components of the device during manufacturing.

FIG. 18 illustrates a variation of a method for using the device with abreast implant in a sagittal view of a breast and surrounding tissue.

FIG. 19 illustrates a variation of a method for using the device with abreast implant in a partial see-through view of a breast and thesurrounding tissue.

DETAILED DESCRIPTION

FIG. 1 illustrates that a surgical attachment device 140, such as areinforcement or bridging patch, can be made from a biologic sheet,backing, matrix, or scaffold 200, and one or more synthetic or otherexogenous reinforcing longitude or longitudinal (or radial) leaders 10 aand/or lateral or latitudinal (or angular) leaders 10 b, such as polymersutures, attached to the scaffold 200. The leaders 10 can be insideand/or outside the material of the scaffold 200. The device 140 candeliver a structural (e.g., biomechnical) supporting force tosurrounding tissue and/or implants.

The scaffold 200 can a collagen sheet with cells removed or otherwisemade animal tissue, such as an extracellular matrix (ECM) derived fromthe forestomach of a ruminant, such as a sheep. Exemplary scaffolds aredescribed in U.S. Pat. No. 8,415,159, which is incorporated by referenceherein in its entirety. The scaffold 200 can have about 70% or more,more narrowly about 80% or more, for example 100% of the cells, or fromabout 70% to about 80% of the cells removed or disrupted to remove theantigenic component of the disrupted cells.

The scaffold 200 can be made from one of more (e.g., two, four, six, oreight) layers of extracellular matrix. The scaffold and/or individuallayers can have a thickness from about 1 mm to about 4 mm, for exampleabout 1.8 mm. The scaffold and/or individual layers can also have athickness from about 0.1 mm to about 0.2 mm. The layers can be bondedtogether. Bonding may be accomplished by the use of biodegradable ornon-biodegradable suture type materials, such as stitching by theleaders 10, by tissue welding via RF frequency energy, biologic-typeglues such as cyanoacrylate derivatives, fibrin/thrombin; gelatins,gluteraldehydes; or other artificial polymers or combinations thereof.The bonded areas may exist as discrete islands or as a single ormultiple strips or areas of increased polymer or bonding content.

The longitudinal leaders 10 a can intersect the latitudinal leaders 10 bat intersection angles 11. The intersection angles 11 can be from about5° to about 175°, more narrowly from about 45° to about 135°, forexample about 90°. The longitudinal leaders 10 a can be parallel ornon-parallel with each other. The latitudinal leaders 10 b can beparallel or non-parallel with each other.

The leaders 10 can be stitched into or through the scaffold 200. Thestitching can have stitch patterns with stitch lengths from about 1 mmto about 3 mm, for example about 1.5 mm.

The longitudinal leaders 10 a can be spaced apart by a longitudinalleader gap 13 a from about 1 mm to about 25 mm, more narrowly from about1 mm to about 12 mm, for example about 6 mm. The longitudinal leaders 10a can be spaced apart by a longitudinal leader gap 13 a from about 1 mmto about 25 mm, more narrowly from about 1 mm to about 12 mm, forexample about 6 mm. The leader gaps 13 can remain constant (as shown inFIG. 1) or vary (as shown in FIG. 5) across the length and/or width ofthe device 140.

The leaders 10 can be made from any of the materials disclosed herein orcombinations thereof, such as a non-biodegrading polymer, such aspolypropylene, ultra-high-molecular-weight polyethylene (UHMWPE), PET,PTFE, ePTFE, or combinations thereof. The leaders 10 can bemonofilaments or multifilaments. The leaders 10 and/or the filaments canhave diameters from about 0.002 in. to about 0.02 in., more narrowlyfrom about 0.002 in. to about 0.01 in., yet more narrowly from about0.006 in. to about 0.008 in., for example about 0.008 in.

The longitudinal leaders 10 a can extend across 90% or more, for exampleacross the entire length, of the scaffold 200 and/or device 140, forexample extending from the bottom (as seen in the figure relative to thepage) terminal edge to the top terminal edge. The lateral leaders 10 bcan extend across 90% or more, for example across the entire length, ofthe scaffold 200 and/or device 140, for example extending from the left(as seen in the figure relative to the page) terminal edge to the rightterminal edge.

The device 140 can have a square or rectangular shape.

FIG. 2 illustrates that the device 140 can have a crescent shape. Thecrescent shape can have a left corner point or tip 18 a and a rightcorner point or tip 18 b. The device 140 can have a curved, convexdistal edge 14 (for attachment to a soft tissue, such as muscle awayfrom the center of the body) and a curved, concave proximal edge 16 (forattachment to a bone and/or soft tissue, such as fascia or muscle closerto the center of the body than the distal edge 14).

The device 140 can have longitudinal leaders 10 a, but no lateralleaders 10 b. The longitudinal leaders 10 a can extend from the distaledge 14 to the proximal edge 16.

The longitudinal leaders 10 b can radially extend from a common radialaxis 12. For example, all of the longitudinal leaders can radiallyextend from the same axis, or laterally symmetric pairs of longitudinalleaders 10 b can extend from common radial axes, such as the firstradial axis 12 a and the second radial axis 12 b. The radial axis oraxes 12 can be located not on or extending through the device 140. Theradial axis or axes 12 can be located distal of the distal edge 14(i.e., with the longitudinal leaders 10 a extending apart from eachother as they approach the proximal edge 16) or proximal of the proximaledge 16 (i.e., with the longitudinal leaders 10 a extending apart fromeach other as they approach the distal edge 14). The longitudinalleaders 10 a can extend in substantially straight (as shown) or curveddirections, as viewed from above or below the device 140.

FIG. 3 illustrates that the radial axis 12 can be located on and/orextend through the device 140. The radial axis 12 can be located closerto the proximal edge 16 (as shown) distal edge 14, or evenly between thetwo edges 14 and 16. The radial axis 12 can be located laterallycentered (as shown) to the device 14 or laterally off-center to thedevice 14.

FIG. 4 illustrates that the device 140 can have latitudinal leaders 10b, but no longitudinal leaders 10 b. The latitudinal leaders 10 b canextend around a common radial axis 12 along the entire length of thelatitudinal leaders or at a given radius extending through thelatitudinal leaders 10 b. The latitudinal leaders 10 b can extend insubstantially straight or curved (oval, as shown, but also can becircular), as viewed from above or below the device 140.

FIG. 5 illustrates that the crescent-shaped device 140 can havelongitudinal and latitudinal leaders 10 a and 10 b. The device 140 canhave the same or differing densities and/or quantities of longitudinalleaders 10 a compared to lateral leaders 10 b.

FIG. 6 illustrates that the distal edge 14 can be convex.

The longitudinal leaders 10 a (as shown) and/or latitudinal leaders 10 bcan have sinusoidal and/or zig-zag (e.g., Z-shaped, W-shaped, andV-shaped), as shown, stitching patterns. The leaders 10 can form rightangles in the stitching patterns. The longitudinal leaders 10 b can belonger in the lateral center of the device 140 and shorter toward eachof the lateral sides of the device 140.

Longitudinal leaders 10 a and/or latitudinal leaders 10 b can terminateat the edges 14 and 16 or tips 18 (as shown for the longitudinal leaders10 a), and/or terminate before the edges 14 and 16 or tips 18, and/orcan return to traverse the scaffold 200 without terminating at the edges14 and 16 or tips 18 (as shown for the latitudinal leaders 10 b).

FIG. 7 illustrates that the device 140 can have reinforced anchors 20 atthe tips 18. The anchors 20 can be or have a higher concentration ofpolymer and/or thicker scaffolding (e.g., with more or thicker layersthan the remainder of the device 140). For example, the anchors 20 canbe or have polymer caps. The anchors 20 can be a significantly higherdensity (e.g., more than three times) of leaders 10 than the density ofleaders 10 in the remainder of the device 140. The anchors can be formedby increasing the relative percent bonding content, by increasing theamount or layers of scaffold tissue matrix material, or combinationsthereof. The anchors 20 can be over or embedded in the scaffold 200. Theanchors 20 can have smooth edges.

During use, the device 140 can be inserted to the target site andattached to the target site solely with attachment elements, such ashooks, brads, staples, sutures, or combinations thereof, through theanchors 20.

FIG. 8 illustrates that the anchors 20 can have irregular-shaped edges.For example, the edge of the anchors 20 attaching to the scaffold 200can be pointed or spiky. The anchoring force load can be passivelydistributed across the edge of the anchor 20 to the scaffold 200.

FIG. 9 illustrates that the anchor 20 can extend from left tip 18 a tothe right tip 18 b along the proximal edge 16 (as shown) and/or thedistal edge 14. The anchor 20 can extend partially along one or bothedges 14 and 16 without extending to one or both tips 18.

The anchors 20 can provide points for surgical attachment, provide areasof increased strength or thickness where increased stress is expectedpost operatively, aid in producing a post-surgical shape of the device140, or combinations thereof.

FIG. 10 illustrates that the device 140 can have one or more extensionflaps or fillers 22 extending proximally from the proximal edge 16 (asshown) and/or distal edge 14. The fillers 22 can be laterally symmetric(as shown) or asymmetric. The fillers 22 can be square, rectangular,circular, oval, or cut-off portions of those shapes. The fillers 22 canbe extensions of the scaffold 200 or different material than thescaffold 200. The fillers 22 can have the same, a thinner, or a thickerthickness than the scaffold 200.

FIG. 11 illustrates that the device can have tabs, tethers, or tipextenders 24 extending in a distal direction from the distal edge 14.The extenders 24 can be laterally symmetric (as shown) or asymmetric.The extenders 24 can be extensions of the scaffold 200 or differentmaterial than the scaffold 200. The extenders 24 can have the same, athinner, or a thicker thickness than the scaffold 200.

The fillers 22 and/or extenders 24 can be used for surgical attachmentand/or manipulation.

FIG. 12a illustrates that one or more of the leaders 10 (theproximal-most latitudinal leader 10 b is shown) can have both of itsleader terminal ends 26 that can be loose and extend out of the scaffold200, for example in the direction of the distal edge 14 or proximal edge16 (as shown). The leader terminal ends 26 can be pulled to tension therespective leader and cinch the device 140 (e.g., a “purse string” or“shoe string” effect).

FIG. 12b illustrates that a first latitudinal leader 10 b′ can have afirst leader terminal end 26 a that can extend out of the scaffold 200at the right tip 18 b, and a second terminal end that can terminate inthe scaffold 200. A second latitudinal leader 10 b″ can have a secondleader terminal end 26 b that can extend out of the scaffold 200 at theleft tip 18 a, and a second terminal end that can terminate in thescaffold 200. The first latitudinal leader 10 b′ can be the adjacentlatitudinal leader to the second latitudinal leader 10 b″.

FIG. 12c illustrates that a first tensioning force, shown by arrow 28 a,can be applied to the first leader terminal end 26 a in the terminaldirection of the first leader terminal end 26 a. A second tensioningforce, shown by arrow 28 b, can be applied to the second leader terminalend 26 b in the terminal direction of the second leader terminal end 26b. The tensioning forces 28 can cause the first and second latitudinalleaders 10 b′ and 10 b″ to deliver a cinching force, shown by arrows 30,to the scaffold 200 adjacent to the respective leaders 10 b′ and 10 b″.

FIG. 13 illustrates that the device 140 and/or scaffold 200 can haveround (as shown) or square pores 30 with pore diameters or widths fromabout from about 1 mm to about 12 mm, for example about 6 mm.

One or more of the scaffold's layers 32, such as an inner layer 32 a,middle layer 32 b, and outer layer 32 c, can have pores 30. The pores 30can completely or partially align (i.e., be congruent) between thelayers 30, for example creating an open channel and allowing fluidcommunication between the external sides or faces of the scaffold 200.The pores 30 can be offset between the layers 32 forming a tortuous orincomplete path between the external sides or faces of the scaffold 200.

Tissue ingrowth (i.e., repopulation) can pass through the pores 30.Biological or other fluids can pass through the pores 30. For example,drainage through the pores 30 can decrease seroma formation. The pores30 can be slits (e.g., wherein no material has been removed), and/orholes (e.g., created by the removal of material).

FIGS. 14a through 14c illustrate that the scaffold 200 can have ascaffold first panel 220 and a scaffold second panel 221. The scaffoldfirst and second panels 220 and 221 can be bonded to each other along aseam or margin 230. The device 140 can have a cupped or bowled shapewith a cavity.

Any or all elements of the device 140 and/or other devices orapparatuses described herein can be made from, for example, a single ormultiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol),cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin,Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.),nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial TradingCompany, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZMalloy, for example as disclosed in International Pub. No. WO 03/082363A2, published 9 Oct. 2003, which is herein incorporated by reference inits entirety), tungsten-rhenium alloys, for example, as disclosed inInternational Pub. No. WO 03/082363, polymers such as polyethyleneteraphthalate (PET), polyester (e.g., DACRON® from E. I. Du Pont deNemours and Company, Wilmington, Del.), poly ester amide (PEA),polypropylene, aromatic polyesters, such as liquid crystal polymers(e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra-highmolecular weight polyethylene (i.e., extended chain, high-modulus orhigh-performance polyethylene) fiber and/or yarn (e.g., SPECTRA® Fiberand SPECTRA® Guard, from Honeywell International, Inc., Morris Township,N.J., or DYNEEMA® from Royal DSM N.V., Heerlen, the Netherlands),polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone(PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK)(also poly aryl ether ketone ketone), nylon, polyether-blockco-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France),aliphatic polyether polyurethanes (e.g., TECOFLEX® from ThermedicsPolymer Products, Wilmington, Mass.), polyvinyl chloride (PVC),polyurethane, thermoplastic, fluorinated ethylene propylene (FEP),absorbable or resorbable polymers such as polyglycolic acid (PGA),poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic acid(PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone(PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen,silicone, zinc, echogenic, radioactive, radiopaque materials, abiomaterial (e.g., cadaver tissue, collagen, allograft, autograft,xenograft, bone cement, morselized bone, osteogenic powder, beads ofbone) any of the other materials listed herein or combinations thereof.Examples of radiopaque materials are barium sulfate, zinc oxide,titanium, stainless steel, nickel-titanium alloys, tantalum and gold.

The device 140 can be made from substantially 100% PEEK, substantially100% titanium or titanium alloy, or combinations thereof.

Any or all elements of the device 140 and/or other devices orapparatuses described herein, can be, have, and/or be completely orpartially coated with agents for cell ingrowth.

The device 140 and/or elements of the device and/or other devices orapparatuses described herein can be filled, coated, layered and/orotherwise made with and/or from cements, fillers, and/or glues known toone having ordinary skill in the art and/or a therapeutic and/ordiagnostic agent. Any of these cements and/or fillers and/or glues canbe osteogenic and osteoinductive growth factors.

Examples of such cements and/or fillers includes bone chips,demineralized bone matrix (DBM), calcium sulfate, corallinehydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate,polymethyl methacrylate (PMMA), biodegradable ceramics, bioactiveglasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs)such as recombinant human bone morphogenetic proteins (rhBMPs), othermaterials described herein, or combinations thereof.

The agents within these matrices can include any agent disclosed hereinor combinations thereof, including radioactive materials; radiopaquematerials; cytogenic agents; cytotoxic agents; cytostatic agents;thrombogenic agents, for example polyurethane, cellulose acetate polymermixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious,hydrophilic materials; phosphor cholene; anti-inflammatory agents, forexample non-steroidal anti-inflammatories (NSAIDs) such ascyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, forexample ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, forexample ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamicacid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., WhitehouseStation, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®,from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP)inhibitors (e.g., tetracycline and tetracycline derivatives) that actearly within the pathways of an inflammatory response. Examples of otheragents are provided in Walton et al, Inhibition of Prostoglandin E₂Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999,48-54; Tambiah et al, Provocation of Experimental Aortic InflammationMediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940;Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and ItsEffect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6),771-775; Xu et al, Spl Increases Expression of Cyclooxygenase-2 inHypoxic Vascular Endothelium, J. Biological Chemistry 275 (32)24583-24589; and Pyo et al, Targeted Gene Disruption of MatrixMetalloproteinase-9 (Gelatinase B) Suppresses Development ofExperimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105(11), 1641-1649 which are all incorporated by reference in theirentireties.

Method of Making

FIGS. 15 and 16 illustrate that during manufacturing of the device 140,the scaffold 200 can be stitched with the leaders 10 in desiredpatterns. The scaffold 200 and stitching of the leaders 10 can extendbeyond the dimensions of the desired device 140. The device 140 can thenbe cut (e.g., die cut or laser cut) out of the scaffold 200 andstitching of leaders 10.

For example, FIG. 15 shows a variation for making the device 140 of FIG.1 before the device 140 is cut from the scaffold 200. A die in the shapeof the device 140 can cut the device 140 from the scaffold 200. Excesslength of the longitudinal stitches 10 a and scaffold 200 past bothlongitudinal ends of the device 140 can be cut away by the die.

Similarly, FIG. 16 shows a variation for making a device 140 similar tothe device 140 shown in FIG. 6. Excess length of the scaffold 200 andthe longitudinal and lateral leaders 10 a and 10 b can be cut away fromall sides of the device 140.

FIGS. 17a through 17c illustrate that a first biologic matrix panel 220can have a first edge or margin 230 a. A second biological matrix panel221 can have a second edge or margin 230 b. The first biological matrixpanel 220 can be bonded to the second biological matrix panel 221 alongthe margins 230. Bonding may comprise any of the methods describedwithin this application.

Following the bonding, the device 140 can be in a desiredthree-dimensional shape and curvature, shown by the device 140 in FIGS.14a through 14c . The degree of curvature of the cup of the device 140can be tailored for an individual patient by varying the shape of thebonding margins. The device 140 can have complex anatomical shapes.

Two devices 140 can be made with symmetric or mirrored shapes (e.g., tobe used on opposite breasts on the same patient). The device 140 can besymmetric about a central axis in any of the three orthogonaldimensions.

The panels 220 and 221 can be cut before or after the bonding to thedesired shapes.

Method of Use

The device 140 can be used, for example, during breast reconstruction oraugmentation surgeries. The device 140 can physically support, andprovide surgical manipulation and control of an associated breastimplant.

FIG. 18 illustrates that the surgical attachment device 140 can supporta liquid-filled prosthetic implant 120 placed under the pectoralis majormuscle 100 following a mastectomy procedure. The device 140 can take theshape of the overlying prosthetic implant 120, supporting the implant120 and maintaining the desired contour of the breast reconstruction.

After the implant 120 is inserted into the patient, the proximal edge 16can be inserted and attached to the chest wall. The distal edge 14 canbe attached to the pectoralis major. The tips 18 can be attached to softor hard tissue adjacent to the lateral sides of the breast implant 120.The tips 18 can be the only attachment points or attached to tissue inconjunction with the distal and/or proximal edges 14 and/or 16.Attachment of the device 140 to tissue can be via sutures, staples,brads, hooks, or combinations thereof.

FIG. 19 illustrates that the lower margin of the device 140 can lendadditional support and shape by the nature of a curved shape orengineered curvature, which serves to approximate and define thereconstructed inframammary fold. The engineered curvature can includecurving in three-dimensions. The engineered curvature can approximatethe breast implant, inframammary fold and desired appearance of thereconstructed breast. The engineered curve can eliminate creases orfolds which would be present when using a flat sheet for the samepurpose. By eliminating such folds and creases the breast implant takeson a more natural contour with minimal distortions.

The leaders 10 and leader patterns can impart anisotropic properties tothe device 140. The device 140 can have an initial modulus of elasticity(or rate of length change relative to force applied, for example in thelongitudinal direction) when initially implanted and attached to tissue.This modulus (or rate of length change relative to force applied) can besubstantially identical to that of the scaffold 200. After time elapses,the scaffold 200 can stretch, for example in the longitudinal direction,due to force loads (e.g., supporting a breast implant), whereby theleaders 10 can begin to strain and deliver a resistive force through thedevice 140 not substantially delivered at the time of the initialimplantation and attachment.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. The above-described configurations,elements or complete assemblies and methods and their elements forcarrying out the disclosure, and variations of aspects of the disclosurecan be combined and modified with each other in any combination.

We claim:
 1. A method for using a surgical attachment device comprising:forming the surgical attachment device, wherein forming comprisesstitching at least a length of a first leader through a biologic sheet,wherein the first leader comprises a first synthetic material, andwherein the stitching comprises extending at least a length of the firstleader from a first edge of the biological sheet across the biologicalsheet to a second edge of the biological sheet, and across thebiological sheet to the first edge of the biological sheet; inserting abreast implant into a patient; attaching the surgical attachment deviceadjacent to the breast implant, wherein the surgical attachment devicehas a first post-implantation configuration and a secondpost-implantation configuration, wherein when the surgical attachmentdevice is in the first post-implantation configuration, the first leaderexerts a first resistive force, wherein when the surgical attachmentdevice is in the second post-implantation configuration, the firstleader exerts a second resistive force, and wherein the first resistiveforce is less than the second resistive force.
 2. The device of claim 1,wherein the first synthetic material comprises a non-biodegradablepolymer.
 3. The method of claim 1, further comprising stitching a secondleader through the surgical attachment device.
 4. The method of claim 3,wherein the second leader comprises a second synthetic material.
 5. Themethod of claim 4, wherein the first synthetic material has the sametype of material as the second synthetic material.
 6. The method ofclaim 3, wherein the second leader intersects the first leader.
 7. Themethod of claim 3, wherein the second leader extends from a first edgeto a second edge of the surgical attachment device.
 8. The method ofclaim 1, wherein at least a length of the first leader has a zig-zagshape.
 9. The method of claim 1, wherein at least a length of the firstleader has a sinusoidal shape.
 10. The method of claim 1, wherein thesurgical attachment device comprises collagen.
 11. The method of claim1, wherein the surgical attachment device comprises a first layer and asecond layer.
 12. The method of claim 1, wherein the first leadercomprises a monofilament.
 13. The method of claim 1, wherein the formingfurther comprises cutting a shape of the surgical attachment device outof a biologic sheet.
 14. The method of claim 13, wherein the cuttingcomprises cutting the first leader.
 15. The method of claim 1, whereinthe forming of the attachment device further comprises bonding a firstlayer to a second layer.
 16. A method for using a surgical attachmentdevice comprising: forming the surgical attachment device, whereinforming comprises stitching at least a length of a first leader througha biologic sheet, wherein the first leader comprises a syntheticmaterial, wherein the stitching comprises extending at least a length ofthe first leader from a first edge of the surgical attachment deviceacross the surgical attachment device to a second edge of the surgicalattachment device, and across the surgical attachment device to thefirst edge of the surgical attachment device; inserting an implant intoa target site, wherein at least part of the target site is in a breast;inserting the surgical attachment device into the target site, whereinthe surgical attachment device has a first stretched configuration and asecond stretched configuration, wherein when the surgical attachmentdevice is in the first stretched configuration, the first leader exertsa first resistive force, wherein when the surgical attachment device isin the second stretched configuration, the first leader exerts a secondresistive force, and wherein the second resistive force is more than thefirst resistive force.
 17. The method of claim 16, wherein the insertingof the implant comprises positioning the implant under the pectoralismajor muscle.
 18. The method of claim 16, further comprising attachingthe surgical attachment device to soft and/or hard tissue adjacent tothe implant.
 19. A method for using an implantable support devicecomprising: inserting a support device into a target site, wherein atleast part of the target site is in a breast, and wherein the supportdevice comprises at least a length of a first leader stitched through abiological sheet, wherein at least a length of the first leader extendsfrom a first edge of the biological sheet across the biological sheet toa second edge of the biological sheet, and across the biological sheetto the first edge of the biological sheet, wherein the first leadercomprises a synthetic material, and wherein the biological sheetcomprises a first layer bonded to a second layer, wherein the supportdevice has a first post-implantation configuration and a secondpost-implantation configuration, wherein the biological sheet isstretched more in the second post-implantation configuration than in thefirst post-implantation configuration, and wherein the first leader isstrained more in the second post-implantation configuration than in thefirst post-implantation configuration.
 20. The method of claim 1,further comprising removing antigenic compounds from at least part ofthe biological sheet.